Lynovex in tablet/oral (hard gel capsule) form successfully completed a phase IIa clinical study in the UK in 2014/15. This small clinical trial demonstrated its tolerability and safety in adult CF patients with stable disease and the preliminary efficacy data obtained confirmed the drugs potential utility in addressing the symptoms and infectious case of CF associated lung disease. The first part of a global, pre-registration (CARE-CF) clinical trial for oral Lynovex in acute infectious CF exacerbations recently completed and determined the safety and efficacy of Lynovex gel capsules alongside standard of care therapy in the treatment of CF exacerbations in adult patients Positive Top Line Data from the CARE CF 1 Clinical Study of Oral Lynovex in Cystic Fibrosis Exacerbations. Pivotal clinical trials for oral Lynovex in CF exacerbations are anticipated as commencing in 2019.
The inhaled (dry powder) formulation of Lynovex has recently been optimised and from a platform of very encouraging preclinical efficacy and safety data, NovaBiotics is working towards initiating clinical studies for inhaled Lynovex in 2020.